Mometasone/ formoterol aerosol

Generic Name: mometasone/formoterol (moe-MET-a-sone/for-MOE-ter-ol)
Brand Name: Dulera

Long-acting beta-agonists such as one of the active ingredients in mometasone/formoterol aerosol (formoterol) have been rarely associated with an increased risk of asthma-related death. They may also increase the risk of asthma-related hospitalizations in CHILDREN and TEENAGERS. Mometasone/formoterol aerosol should only be used to treat asthma patients who are not controlled by using other long-term asthma-control medicine. Mometasone/formoterol aerosol should not be used in patients whose asthma is well controlled by inhaled corticosteroids.


Mometasone/ formoterol aerosol is used for:

Treating asthma in certain patients. It may also be used for other conditions as determined by your doctor.

Mometasone/formoterol aerosol is a combination of a corticosteroid and a long-acting beta-agonist bronchodilator. The corticosteroid works by decreasing inflammation in the lungs. The long-acting beta-agonist works by widening the airways in the lungs, which helps you breathe more easily.

Do NOT use mometasone/ formoterol aerosol if:

  • you are allergic to any ingredient in mometasone/formoterol aerosol
  • you are using another medicine that has a long-acting beta-agonist (eg, salmeterol) in it
  • you are having an asthma attack (eg, sudden, severe onset or worsening of asthma symptoms such as wheezing, cough, chest tightness, shortness of breath)
  • you have asthma that is already well controlled with the use of a long-term asthma-control medicine (eg, inhaled corticosteroid)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using mometasone/ formoterol aerosol:

Some medical conditions may interact with mometasone/formoterol aerosol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of diabetes, heart problems (eg, fast, slow or irregular heartbeat, heart blood vessel problems), high blood pressure, high blood acid levels (ketoacidosis), low blood potassium levels, seizures, tuberculosis, a weakened immune system, liver problems, tumor on the adrenal gland (pheochromocytoma), aneurysm, or thyroid problems
  • if you have weakened bones (eg, osteoporosis), a family history of weakened bones, or have other risk factors of weak bones (eg, smoking, poor nutrition, you take certain medicines that weaken bones)
  • if you have a history of eye problems (eg, glaucoma, cataracts, increased eye pressure)
  • if you have diarrhea; a fungal, bacterial, or parasitic infection; a viral infection (eg, chickenpox, measles); herpes infection of the eye; or a lung infection (eg, pneumonia)
  • if you have recently been to an emergency room for asthma, have a history of frequent hospitalizations for asthma, or have ever had a life-threatening asthma attack
  • if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
  • if you are taking a macrolide antibiotic (eg, clarithromycin), a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days
  • if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with mometasone/formoterol aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Beta-agonists (eg, albuterol), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), or xanthines (eg, theophylline) because the risk of low blood potassium or irregular heartbeat may be increased
  • Azole antifungals (eg, itraconazole, ketoconazole), HIV protease inhibitors (eg, atazanavir, indinavir, ritonavir), linezolid, other long-acting beta-agonists (eg, salmeterol), macrolide antibiotics (eg, clarithromycin), MAOIs (eg, phenelzine), nefazodone, telithromycin, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of mometasone/formoterol aerosol's side effects
  • Beta-blockers (eg, propranolol) because they may decrease mometasone/formoterol aerosol's effectiveness or worsen your condition

This may not be a complete list of all interactions that may occur. Ask your health care provider if mometasone/formoterol aerosol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use mometasone/ formoterol aerosol:

Use mometasone/formoterol aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Mometasone/formoterol aerosol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get mometasone/formoterol aerosol refilled.
  • You will need to prime the inhaler before using it for the first time, any time it has not been used for more than 5 days, or if it has been dropped. To prime the inhaler, point it away from you and others. Spray 4 times, shaking well before each spray.
  • Be sure that the canister is properly placed in the inhaler unit. Shake well before each use. Remove the mouthpiece cover. Check the mouthpiece for foreign objects. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow, deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of mometasone/formoterol aerosol. Continue breathing in slowly and deeply and hold for as long as comfortable up to 10 seconds, then breathe out slowly through your nose while keeping your lips closed. If more than 1 inhalation is to be used, wait at least 30 seconds and repeat the above steps. Keep the spray away from your eyes. Close the mouthpiece cover after each use.
  • Rinse your mouth with water after you finish using the medicine (do not swallow). This will help remove excess medicine and decrease your risk of developing an oral fungal infection.
  • Wipe the mouthpiece clean with a dry cloth at least once a week.
  • Use the new inhaler that comes with each refill. Do not reuse an old inhaler. Do not use mometasone/formoterol aerosol with a different kind of inhaler.
  • Never wash the mouthpiece or any other part of the inhaler with water. Keep it dry and always store in a dry place. Do NOT try to take the inhaler apart.
  • This inhaler contains a certain number of doses. A dose counter shows how many puffs are left in the inhaler. The counter will count down each time you release a puff of medicine. Do not use this inhaler after the counter on the inhaler says "0". The inhaler may not feel empty, but you will not get the correct amount of medicine with each spray if you continue to use it.
  • Continue to use mometasone/formoterol aerosol even if you feel well. Do not miss any doses.
  • If you miss a dose of mometasone/formoterol aerosol, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use mometasone/formoterol aerosol.

Important safety information:

  • Mometasone/formoterol aerosol is for oral inhalation only. Do not spray in the eyes. If you get mometasone/formoterol aerosol in the eyes, rinse immediately with cool tap water. If eye redness and irritation continue, contact your doctor.
  • Mometasone/formoterol aerosol may cause dizziness. This effect may be worse if you use it with alcohol or certain medicines. Use mometasone/formoterol aerosol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Some patients may have trouble using mometasone/formoterol aerosol correctly. Some may also get mouth sores or a bad taste in the mouth after using it. If you have any of these problems, ask your health care provider if a spacing device may help.
  • The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use mometasone/formoterol aerosol in high doses. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Mometasone/formoterol aerosol should be used to treat asthma only if your asthma is not well controlled while you are using a certain long-term asthma-control medicine (eg, inhaled corticosteroid) or if you have severe asthma. Contact your doctor if you have questions about this information.
  • Use caution if you switch from an oral steroid (eg, prednisone) to mometasone/formoterol aerosol. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
  • Mometasone/formoterol aerosol may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Tell your doctor right away if you are exposed to anyone who has these infections.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking mometasone/formoterol aerosol. Talk with your doctor before you receive any vaccine.
  • Mometasone/formoterol aerosol will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of mometasone/formoterol aerosol (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
  • If you have been regularly using a short-acting bronchodilator inhaler (eg, albuterol), talk with your doctor about how to use it with mometasone/formoterol aerosol. Short-acting bronchodilators are normally only used with mometasone/formoterol aerosol to treat breathing problems that may occur between doses.
  • Tell your doctor or dentist that you take mometasone/formoterol aerosol before you receive any medical or dental care, emergency care, or surgery.
  • If your symptoms do not get better within 1 to 2 weeks of starting mometasone/formoterol aerosol or if they get worse, contact your doctor right away.
  • Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often (eg, 4 or more times a day for more than 2 days in a row, more than 1 canister in 8 weeks), or if you have a decrease in your peak flow meter results.
  • Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly or if you use your short-acting bronchodilator and do not get relief.
  • Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Your doctor may make changes to your asthma-control medicines once your asthma is well controlled. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
  • The medicine may sometimes cause breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.
  • Lab tests, including lung function, blood pressure, and eye exams, may be performed while you use mometasone/formoterol aerosol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use mometasone/formoterol aerosol with caution in the ELDERLY; they may be more sensitive to its effects, especially weakened bones.
  • Corticosteroids may affect the growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use mometasone/formoterol aerosol.
  • Mometasone/formoterol aerosol should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if mometasone/formoterol aerosol can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using mometasone/formoterol aerosol while you are pregnant. It is not known if mometasone/formoterol aerosol is found in breast milk. If you are or will be breast-feeding while you use mometasone/formoterol aerosol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of mometasone/ formoterol aerosol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; dry mouth; headache; nausea; nervousness; stuffy nose; throat irritation; tiredness; tremor; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; flushing of the skin; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); chest pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased mucus production or change in color of mucus; muscle pain, weakness, or cramps; new or worsening asthma symptoms (eg, coughing, increased chest tightness, shortness of breath, wheezing); seizures; severe or persistent dizziness, headache, light-headedness, nervousness, or tremor; severe or persistent nausea; sluggishness; speech problems; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing of the skin; confusion; fruit-like breath odor); vomiting; white patches in your mouth or throat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; fast breathing; fast or irregular heartbeat; muscle pain, weakness, or cramps; seizures; severe or persistent dizziness, dry mouth, fatigue, headache, light-headedness, nausea, nervousness, trouble sleeping, tremors, or vomiting; severe or unusual drowsiness; shortness of breath; sluggishness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing of the skin; confusion; fruit-like breath odor).

Proper storage of mometasone/formoterol aerosol:

Store mometasone/formoterol aerosol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and direct sunlight. Do not store in the bathroom. Do not puncture, break, or burn the canister even if it appears to be empty. Keep mometasone/formoterol aerosol out of the reach of children and away from pets.

General information:

  • If you have any questions about mometasone/formoterol aerosol, please talk with your doctor, pharmacist, or other health care provider.
  • Mometasone/formoterol aerosol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take mometasone/formoterol aerosol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about mometasone/formoterol aerosol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to mometasone/formoterol aerosol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using mometasone/formoterol aerosol.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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